Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?

Summary

Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.

Conditions

• Acute Kidney Injury
• Septic Shock
• Nicotinamide
• Mortality

Interventions

DRUG

Nicotinamide treatment

Nicotinamide (500 mg) will be mixed in 50 ml of 0.9% saline and administered intravenously every 12 h for a total of 72 h.

DRUG

placebo treatment

For the placebo group, an identical volume of 0.9% saline will be administered in the same manner.

Sponsors & Collaborators

• Centre Hospitalier de Dieppe

  collaborator UNKNOWN

• Centre Hospitalier d'Abbeville

  collaborator OTHER

• Centre Hospitalier de Laon

  collaborator UNKNOWN

• University Hospital, Caen

  collaborator OTHER

• Centre Hospitalier de Cherbourg

  collaborator UNKNOWN

• University Hospital, Rouen

  collaborator OTHER

• Centre Hospitalier de Roubaix

  collaborator OTHER

• Centre Hospitalier de Bethune

  collaborator NETWORK

• Hôpital Saint Philibert, Lomme

  collaborator UNKNOWN

• Tourcoing Hospital

  collaborator OTHER

• Centre Hospitalier de Valenciennes

  collaborator NETWORK

• Centre Hospitalier Arras

  collaborator OTHER

• Centre Hospitalier de Lens

  collaborator OTHER

• Centre Hospitalier de Calais

  collaborator UNKNOWN

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-01

Primary Completion

2025-09-30

Completion

2025-09-30

Countries

• France

Study Locations